Restorative Treatment of Severe Tooth Wear; Direct vs Indirect

Tooth Wear Clinical Trial

Official title:

Restorative Treatment of Severe Tooth Wear; Direct vs Indirect

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04326816
• Other study ID #: 2010/203
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Est. completion date: March 2021

Study information

• Verified date: March 2021
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study compares the survival rates of both direct and indirect resin-based composite restorations in the treatment of severe tooth wear.

Description:

Tooth wear can lead to pain, discomfort and unsatisfying dental attractiveness and when severe, it can compromise the dentition's prognosis. Restorative therapies for treatment of severe tooth wear should be preferably minimally invasive and adhesive. This study compares two different treatment techniques for severe tooth wear. The first technique is regarded as the 'standard' technique. This is a full rehabilitation using only direct composite restorations (AP-X, Kuraray, Japan). The second technique comprises a full rehabilitation using both direct and indirect resin composite restorations (Estenia C&B, Kuraray, Japan). 10 indirect restorations are placed on specific elements i.e. first molars and palatal sides of all maxillary anterior teeth. Other elements are restored conform the direct protocol. An important benefit for the patients is the rehabilitation of their worn dentitions. Functionality (teeth are less sensitive, improved chewing ability, better occlusal stability, etc) and aesthetics will be improved immediately after finishing the treatment. Indirect techniques have the advantage of a superior control over form of restorations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients age of at least 18 years old.
• Generalized moderate to severe tooth wear (Tooth Wear Index (TWI) = 2) with a patient demand for treatment (Smith 1984)
• Full dental arches, but one diastema due to one missing tooth in the posterior area was allowed.
• An estimated need for increase of vertical dimension of occlusion (VDO) of =3mm at the location of the first molars.

Exclusion Criteria:

• Limited mouth opening (<3.5cm).
• (History of) Temporomandibular dysfunction, periodontitis, deep caries lesions or multiple endodontic problems.
• Local or systemic conditions that would contra-indicate dental procedures. Patients with specific individual risk factors, such as parafunctional habits of grinding/clenching or patients with GORD (Gastro Oesophageal Reflex Disease), were not excluded.

Related Conditions & MeSH terms

• Dental Restoration Failure
• Dental Restoration Wear
• Tooth Wear

Intervention

Procedure:
• Rehabilitation of severely worn dentitions using minimally invasive composite restorations (Estenia C&B or Clearfil AP-X, Kuraray, Osaka, Japan)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Ivoclar Vivadent AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure level 1	Number of replaced direct and indirect restorations in the treatment. The higher the number the worse the outcome.	Failures 3 years after placement
Primary	Failure level 2	Number of repaired direct and indirect restorations in the treatment. The higher the number the worse the outcome.	Failures 3 years after placement
Primary	Failure level 3	Number of refurbished direct and indirect restorations in the treatment due to material chippings. The higher the number the worse the outcome.	Failures 3 years after placement